Skip Navigation LinksHome > March 2014 - Volume 33 - Issue 3 > Pharmacokinetics of Pediatric Lopinavir/Ritonavir Tablets in...
Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0000000000000014
HIV Reports

Pharmacokinetics of Pediatric Lopinavir/Ritonavir Tablets in Children When Administered Twice Daily According to FDA Weight Bands

Bastiaans, Diane E. T. PharmD*; Forcat, Silvia PharmD, PhD; Lyall, Hermione MB ChB(Hons), MD, FRCPCH; Cressey, Tim R. PhD§; Hansudewechakul, Rawiwan MD; Kanjanavanit, Suparat MD; Noguera-Julian, Antoni MD, PhD**; Königs, Christoph MD††; Inshaw, Jamie R. J. MSc; Chalermpantmetagul, Suwalai RN, MSc§; Saïdi, Yacine PhD‡‡; Compagnucci, Alexandra MD‡‡; Harper, Lynda M. MSc; Giaquinto, Carlo MD§§; Colbers, Angela P. H. MSc*; Burger, David M. PharmD, PhD*

Supplemental Author Material
Collapse Box

Abstract

Background:

Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval and only body surface area by the EMA. This can lead to a different recommended dose. In addition, weight band–based dosing has not been formally studied in the target population. We evaluated the pharmacokinetics (PK) of LPV/r in children, administered twice daily according to the FDA weight bands, using pediatric tablets.

Methods:

Fifty-three HIV-infected children were included in the PK substudy of the Paediatric European Network for the Treatment of AIDS 18 trial (KONCERT). In this study, children were randomized to receive LPV/r twice or once daily, according to FDA weight bands. A PK assessment was performed in 17, 16 and 20 children in the 15–25 kg, ≥25–35 kg and >35 kg weight band, respectively, while children took the tablets twice daily. Rich sampling was performed, and PK parameters were calculated by noncompartmental analysis. Given the high percentage of Asian children, it was also tested whether there was a difference in PK parameters between Asian and non-Asian children.

Results:

For the total group, LPV geometric mean AUC0–12, Cmax and C12 were 106.9 h × mg/L, 12.0 mg/L and 4.9 mg/L, respectively. There were no significant differences in LPV PK parameters between the weight bands. In addition, weight was not found to be associated with variability in Cmax, C12 or AUC0–12 for the LPV PK parameters.

Conclusions:

FDA weight band–based dosing recommendations provide adequate exposure to LPV when using LPV/r pediatric tablets.

Copyright © 2013 by Lippincott Williams & Wilkins

Login

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.